1. Monitoring: Conducting on-site visits to clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulations.
2. Data Collection and Validation: Reviewing and verifying clinical data collected during the trial to ensure accuracy, completeness, and adherence to protocols.
3. Investigator Support: Assisting and training investigators and site staff on study procedures, data collection, and regulatory requirements.
4. Site Management: Overseeing the overall progress of clinical trials at various investigative sites, ensuring timely recruitment, and resolving any issues that may arise.
5. Regulatory Compliance: Ensuring that all trial-related documents are maintained and updated as per regulatory requirements.
6. Safety Reporting: Monitoring and reporting adverse events and serious adverse events to regulatory authorities and the sponsor.
7. Communication: Maintaining regular communication with study sponsors, investigators, and other stakeholders to provide updates on trial progress.
8. Document Management: Managing trial-related documentation, such as study protocols, case report forms, and informed consent forms.
9. Quality Assurance: Participating in quality control activities to ensure the integrity and reliability of trial data.
10. SOP Adherence: Adhering to Standard Operating Procedures (SOPs) and contributing to their development and improvement.
• CRAs play a vital role in ensuring the successful conduct of clinical trials while maintaining the highest standards of patient safety and data integrity.
#clinicalresearch #clinicalresearchassociate #cra #dataanalysis #datamonitoring #datacollection #qualityassurance #pharmajobs #jobsearch #connections #helpinghands #pharmadrx